atai Life Sciences Announces Positive Topline Results from Beckley Psytech’s BPL-003 (intranasal 5-MeO-DMT benzoate) Phase 2a Open-Label Study for Alcohol Use Disorder
atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Beckley Psytech's Phase 2a open-label study of BPL-003, a synthetic intranasal formulation of 5-MeO-DMT benzoate, in treating alcohol use disorder (AUD). The study, involving 12 patients with moderate to severe AUD, demonstrated significant improvements following a single dose combined with relapse prevention therapy:
Key results after 12 weeks include:
- Reduction in daily alcohol consumption from 9.3 to 2.2 units
- Decrease in heavy drinking days from 56% to 13%
- Increase in abstinent days from 33% to 81%
- 50% of patients maintained complete abstinence
The treatment was well-tolerated with only mild to moderate adverse events reported, and patients were typically ready for discharge within two hours. Beckley Psytech plans to evaluate future development options and share additional clinical data throughout 2025.
atai Life Sciences (NASDAQ: ATAI) ha anunciato risultati positivi preliminari dallo studio open-label di fase 2a di Beckley Psytech su BPL-003, una formulazione intranasale sintetica di 5-MeO-DMT benzoato, per il trattamento del disturbo da uso di alcol (AUD). Lo studio, che ha coinvolto 12 pazienti con AUD da moderato a grave, ha dimostrato significativi miglioramenti dopo una singola dose combinata con una terapia di prevenzione delle ricadute:
I risultati chiave dopo 12 settimane includono:
- Riduzione del consumo quotidiano di alcol da 9,3 a 2,2 unità
- Diminuzione dei giorni di forte consumo da 56% a 13%
- Aumento dei giorni di astinenza da 33% a 81%
- Il 50% dei pazienti ha mantenuto l'astinenza completa
Il trattamento è stato ben tollerato con solo eventi avversi lievi o moderati riportati, e i pazienti erano tipicamente pronti per la dimissione entro due ore. Beckley Psytech prevede di valutare opzioni di sviluppo future e condividere ulteriori dati clinici nel corso del 2025.
atai Life Sciences (NASDAQ: ATAI) anunció resultados positivos preliminares del estudio abierto de fase 2a de Beckley Psytech sobre BPL-003, una formulación intranasal sintética de 5-MeO-DMT benzoato, en el tratamiento del trastorno por consumo de alcohol (AUD). El estudio, que involucró a 12 pacientes con AUD de moderado a severo, demostró mejoras significativas tras una sola dosis combinada con terapia de prevención de recaídas:
Los resultados clave después de 12 semanas incluyen:
- Reducción del consumo diario de alcohol de 9.3 a 2.2 unidades
- Disminución de los días de consumo excesivo del 56% al 13%
- Aumento de los días de abstinencia del 33% al 81%
- El 50% de los pacientes mantuvieron la abstinencia completa
El tratamiento fue bien tolerado, con solo eventos adversos leves a moderados reportados, y los pacientes estaban típicamente listos para el alta en un plazo de dos horas. Beckley Psytech planea evaluar opciones de desarrollo futuras y compartir datos clínicos adicionales a lo largo de 2025.
atai Life Sciences (NASDAQ: ATAI)는 Beckley Psytech의 BPL-003에 대한 2a 단계 오픈 라벨 연구의 긍정적인 초기 결과를 발표했습니다. BPL-003은 알코올 사용 장애(AUD)를 치료하는 5-MeO-DMT 벤조산의 합성 비강 투여 제형입니다. 이 연구는 중등도에서 심한 AUD를 가진 12명의 환자를 포함하여 단일 용량을 재발 방지 치료와 결합하여 중요 개선 사항을 보여주었습니다:
12주 후 주요 결과는 다음과 같습니다:
- 일일 알코올 소비량이 9.3에서 2.2 단위로 감소
- 심각한 음주일 수가 56%에서 13%로 감소
- 금주일 수가 33%에서 81%로 증가
- 환자의 50%가 완전 금주를 유지
치료는 잘 견디어졌으며, 보고된 부작용은 경미하거나 중등도였고, 환자는 일반적으로 2시간 이내에 퇴원 준비가 되었습니다. Beckley Psytech는 향후 개발 옵션을 평가하고 2025년 동안 추가 임상 데이터를 공유할 계획입니다.
atai Life Sciences (NASDAQ: ATAI) a annoncé des résultats préliminaires positifs de l'étude open-label de phase 2a de Beckley Psytech sur BPL-003, une formulation intranasale synthétique de 5-MeO-DMT benzoate, dans le traitement du trouble lié à l'usage de l'alcool (AUD). L'étude, impliquant 12 patients présentant un AUD léger à sévère, a montré des améliorations significatives après une seule dose associée à une thérapie de prévention des rechutes :
Les résultats clés après 12 semaines comprennent :
- Réduction de la consommation quotidienne d'alcool de 9,3 à 2,2 unités
- Diminution des jours de consommation excessive de 56 % à 13 %
- Augmentation des jours d'abstinence de 33 % à 81 %
- 50 % des patients ont maintenu une abstinence complète
Le traitement a été bien toléré avec seulement des effets indésirables légers à modérés signalés, et les patients étaient généralement prêts à être libérés dans les deux heures. Beckley Psytech prévoit d'évaluer les options de développement futures et de partager des données cliniques supplémentaires tout au long de l'année 2025.
atai Life Sciences (NASDAQ: ATAI) hat positive vorläufige Ergebnisse aus der offenen Phase-2a-Studie von Beckley Psytech zu BPL-003, einer synthetischen intranasalen Formulierung von 5-MeO-DMT-Benzoat, zur Behandlung von Alkoholgebrauchsstörungen (AUD) angekündigt. Die Studie, an der 12 Patienten mit moderaten bis schweren AUD teilnahmen, zeigte signifikante Verbesserungen nach einer einzigen Dosis in Kombination mit einer Rückfallpräventionstherapie:
Wichtige Ergebnisse nach 12 Wochen sind:
- Reduktion des täglichen Alkoholkonsums von 9,3 auf 2,2 Einheiten
- Abnahme der Tage mit starkem Trinken von 56% auf 13%
- Steigerung der Abstinenztage von 33% auf 81%
- 50% der Patienten hielten die vollständige Abstinenz aufrecht
Die Behandlung wurde gut vertragen, mit nur milden bis moderaten unerwünschten Ereignissen, und die Patienten waren typischerweise innerhalb von zwei Stunden bereit zur Entlassung. Beckley Psytech plant, zukünftige Entwicklungsoptionen zu bewerten und im Laufe des Jahres 2025 zusätzliche klinische Daten zu teilen.
- Single dose efficacy demonstrated with 50% of patients maintaining complete abstinence for 12 weeks
- Significant reduction in daily alcohol consumption from 9.3 to 2.2 units
- Heavy drinking days decreased substantially from 56% to 13%
- Abstinent days increased significantly from 33% to 81%
- Well-tolerated safety profile with no serious adverse events
- Short treatment time with discharge within approximately 2 hours
- Small sample size of only 12 patients
- Open-label study design lacking placebo control
Insights
These Phase 2a results represent a potentially transformative approach in AUD treatment. The 81% abstinent days at Week 12 significantly outperforms current standard-of-care medications like naltrexone and acamprosate, which typically achieve 20-30% abstinence rates. The single-dose administration paradigm could revolutionize AUD treatment compliance, addressing a critical challenge in current therapies that require daily medication.
Several aspects particularly stand out: 1) The rapid onset and short clinic time (~2 hours) could enable high patient throughput and cost-effective treatment delivery; 2) The sustained effect over 12 weeks from a single dose suggests potential epigenetic or neuroplastic changes, distinguishing it from traditional daily medications; 3) The combination with cognitive behavioral therapy indicates a thoughtful approach to both biological and psychological aspects of addiction.
While promising, it's important to note study limitations: the small sample size (n=12) and open-label design warrant larger, randomized controlled trials to confirm efficacy. The 50% complete abstinence rate is remarkable but needs validation in a larger cohort. The safety profile appears favorable for clinical implementation, though longer-term follow-up will be essential.
These results significantly de-risk ATAI's investment in Beckley Psytech and validate their strategic approach to mental health treatment. The global AUD treatment market, valued at approximately
Key value drivers include: 1) The single-dose treatment model could command premium pricing while reducing overall healthcare costs through improved compliance and reduced hospitalization; 2) The short treatment time enables efficient clinic utilization and scalability; 3) The combination with standard therapy suggests easier integration into existing treatment infrastructure.
The upcoming Phase 2b data in treatment-resistant depression mid-year could provide additional validation of the platform, potentially creating multiple value-generating catalysts. The well-tolerated safety profile and rapid treatment protocol position BPL-003 favorably against both traditional AUD treatments and emerging psychedelic therapeutics.
- A single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with
- BPL-003 was well-tolerated with no serious or severe adverse events reported
NEW YORK and BERLIN, Jan. 28, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced positive topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder (AUD). BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time. The results showed that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, induced meaningful and sustained reduction in alcohol use and heavy drinking days (HDDs) in patients with moderate to severe AUD out to 12 weeks.
“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” stated Dr. Srinivas Rao, CEO and Co-founder of atai. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders. We look forward to the Phase 2b data readout of BPL-003 in treatment-resistant depression expected mid-year.”
The 12-week Phase 2a open-label study enrolled 12 patients with moderate to severe AUD and evaluated the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy (NCT05674929). The results demonstrated meaningful and sustained reductions in alcohol use following a single dose of BPL-003:
- Mean number of alcohol units consumed per day decreased from 9.3 units to 2.2 units at Week 12
- Mean percentage of HDDs, defined as consuming seven or more units of alcohol per day for women and nine or more units of alcohol per day for men, declined from
56% to13% at Week 12 - Mean number of abstinent days increased from
33% to81% at Week 12 50% of the patients remained completely abstinent through the 12-week study
BPL-003 was shown to be well-tolerated with adverse events (AEs) being reported as mild or moderate and there were no serious or severe adverse events reported. Most patients were assessed as ready for discharge within approximately two hours.
Beckley Psytech plans to evaluate future development options for BPL-003 in substance use disorders and anticipates reporting additional clinical data from this study in publications and conferences in 2025.
About Alcohol Use Disorder (AUD)
AUD is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. The World Health Organization estimates that around 400 million people suffer with AUD worldwide, with around 3 million deaths each year attributed to the harmful use of alcohol. Currently available pharmacological treatment options are not very effective and some people with alcohol use disorder who wish to abstain from, or reduce, alcohol consumption do not achieve their treatment goal with currently approved treatment options. This contributes to an unmet need for more effective medical treatments.
About BPL-003
BPL-003 is Beckley Psytech’s patent-protected synthetic intranasal 5-MeO-DMT benzoate formulation, designed to deliver rapid and durable effects from a single dose, with a short time in clinic. PL-003 is being investigated for treatment resistant depression (TRD) and for alcohol use disorder (AUD). In a Phase 2a study TRD study, a single 10mg dose of BPL-003 produced a rapid antidepressant response in
About Beckley Psytech Ltd
Beckley Psytech Ltd. is a private clinical-stage biopharmaceutical company dedicated to improving the lives of people with neuropsychiatric disorders through the development of rapid-acting, short-duration psychedelic medicines. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. The Company was founded in response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to developing novel, evidence-based therapeutics to treat depression, anxiety and other mental health disorders. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our business strategy and plans; and the potential, success, cost and timing of development of our product candidates, and the product candidates of those companies we invest in, including the progress of preclinical and clinical trials and related milestones such as BPL-003 and related data readouts.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 28, 2024, as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
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